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Does the Therapist's Assessment of Movement Control in Low Back Pain Patients Correspond to an Objective Kinematic Modification (LOBACOM)

Primary Purpose

Chronic Low-back Pain

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
motion control fault tests
Sponsored by
University Hospital, Brest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Low-back Pain focused on measuring Low back pain, Movement control, Kinematic analysis, Clinical assessment

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged more than 18 years
  • Common low back pain (non-specific) with medical prescription
  • Signed consent

Exclusion Criteria:

  • Body Mass Index greater than 30 (obesity)
  • Person who does not understand French
  • Pregnant woman
  • Refusal to participate
  • Volunteer under guardianship or curatorship

Sites / Locations

  • CHU de BrestRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

motion control fault testing

Arm Description

Each patient make six motion control fault tests in the same order : "waiters bow" "pelvic tilt" "one leg stance" "sitting knee extension" "rocking 4 point kneeling" "prone knee bend" This tests are performed three times.

Outcomes

Primary Outcome Measures

Range of compensation motion : "waiters bow" test
Lumbar flexion measured for test number 1 "waiters bow". Patients are filmed during the test. Videos are watched by three physiotherapists. They going to establish a diagnostic normal or abnormal
Range of compensation motion : "pelvic tilt" test
thoracic flexion measured for test number 2 "pelvic tilt". Patients are filmed during the test. Videos are watched by three physiotherapists. They going to establish a diagnostic normal or abnormal.
Range of compensation motion : "One leg stance" test
Pelvic shift measured for test number 3 "One leg stance ". Patients are filmed during the test. Videos are watched by three physiotherapists. They going to establish a diagnostic normal or abnormal.
Range of compensation motion : "sitting knee extension" test
Lumbar flexion measured for test number 4 "sitting knee extension". Patients are filmed during the test. Videos are watched by three physiotherapists. They going to establish a diagnostic normal or abnormal.
Range of compensation motion : "rocking 4 point kneeling" test
Lumbar flexion and extension measured for test number 5 "rocking 4 point kneeling ". Patients are filmed during the test. Videos are watched by three physiotherapists. They going to establish a diagnostic normal or abnormal.
Range of compensation motion : "prone knee bend" test
Lumbar extension measured for test number 6 "prone knee bend". Patients are filmed during the test. Videos are watched by three physiotherapists. They going to establish a diagnostic normal or abnormal

Secondary Outcome Measures

Speed of execution for test 1
It is measured with a camera. The camera can film one hundred pictures per second. Speed of execution is measured in seconds.
Speed of execution for test 2
It is measured with a camera. The camera can film one hundred pictures per second. Speed of execution is measured in seconds.
Speed of execution for test 3
It is measured with a camera. The camera can film one hundred pictures per second. Speed of execution is measured in seconds.
Speed of execution for test 4
It is measured with a camera. The camera can film one hundred pictures per second. Speed of execution is measured in seconds.
Speed of execution for test 5
It is measured with a camera. The camera can film one hundred pictures per second. Speed of execution is measured in seconds.
Speed of execution for test 6
It is measured with a camera. The camera can film one hundred pictures per second. Speed of execution is measured in seconds.

Full Information

First Posted
August 19, 2022
Last Updated
July 12, 2023
Sponsor
University Hospital, Brest
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1. Study Identification

Unique Protocol Identification Number
NCT05511012
Brief Title
Does the Therapist's Assessment of Movement Control in Low Back Pain Patients Correspond to an Objective Kinematic Modification
Acronym
LOBACOM
Official Title
Does the Therapist's Assessment of Movement Control in Low Back Pain Patients Correspond to an Objective Kinematic Modification
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2022 (Actual)
Primary Completion Date
December 15, 2024 (Anticipated)
Study Completion Date
December 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Exercise-based treatment is part of the recommendations for good practice in the treatment of low back pain (acute, sub-acute and chronic). The low back pain population is heterogeneous. This heterogeneity would cause the positive effects of a treatment to be canceled out by the negative effects of another part of the population. This polymorphism has led several authors to classify low back pain into subgroups. These subgroups constitute more homogeneous clinical pictures and would facilitate the adaptation of treatments. The recommendations of the American Physical Therapy Association suggest 5 subgroups of low back pain. One of them is "low back pain with movement coordination defect". In this subgroup, Luomajoki studied the reliability of different functional tests used in clinical practice. 6 out of 10 motion control fault tests show good reliability. The quantified analysis of the movement of low back pain patients would make it possible to determine the sensitivity of detecting an anomaly in the 6 lumbar movement control tests.
Detailed Description
Exercise-based treatment is part of the recommendations for good practice in the treatment of low back pain (acute, sub-acute and chronic). The low back pain population is heterogeneous. This heterogeneity would cause the positive effects of a treatment to be canceled out by the negative effects of another part of the population. This polymorphism has led several authors to classify low back pain into subgroups. These subgroups constitute more homogeneous clinical pictures and would facilitate the adaptation of treatments. The recommendations of the American Physical Therapy Association suggest 5 subgroups of low back pain. One of them is "low back pain with movement control impairment". In this subgroup, Luomajoki studied the reliability of different functional tests used in clinical practice. 6 out of 10 motion control fault tests show good reliability. The quantified analysis of the movement of low back pain patients would make it possible to determine the sensitivity of detecting an anomaly in the 6 lumbar movement control tests. LoBaCoM is a monocentric, exploratory prospective study. The purpose is to define a kinematic (angular) threshold corresponding to an anomaly detected clinically by three therapists for each test.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain
Keywords
Low back pain, Movement control, Kinematic analysis, Clinical assessment

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
It is a prospective, monocentric, exploratory study
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
motion control fault testing
Arm Type
Other
Arm Description
Each patient make six motion control fault tests in the same order : "waiters bow" "pelvic tilt" "one leg stance" "sitting knee extension" "rocking 4 point kneeling" "prone knee bend" This tests are performed three times.
Intervention Type
Other
Intervention Name(s)
motion control fault tests
Intervention Description
Patients make 6 motion control fault tests, in the same order. Each test is performed three times
Primary Outcome Measure Information:
Title
Range of compensation motion : "waiters bow" test
Description
Lumbar flexion measured for test number 1 "waiters bow". Patients are filmed during the test. Videos are watched by three physiotherapists. They going to establish a diagnostic normal or abnormal
Time Frame
Day 0
Title
Range of compensation motion : "pelvic tilt" test
Description
thoracic flexion measured for test number 2 "pelvic tilt". Patients are filmed during the test. Videos are watched by three physiotherapists. They going to establish a diagnostic normal or abnormal.
Time Frame
Day 0
Title
Range of compensation motion : "One leg stance" test
Description
Pelvic shift measured for test number 3 "One leg stance ". Patients are filmed during the test. Videos are watched by three physiotherapists. They going to establish a diagnostic normal or abnormal.
Time Frame
Day 0
Title
Range of compensation motion : "sitting knee extension" test
Description
Lumbar flexion measured for test number 4 "sitting knee extension". Patients are filmed during the test. Videos are watched by three physiotherapists. They going to establish a diagnostic normal or abnormal.
Time Frame
Day 0
Title
Range of compensation motion : "rocking 4 point kneeling" test
Description
Lumbar flexion and extension measured for test number 5 "rocking 4 point kneeling ". Patients are filmed during the test. Videos are watched by three physiotherapists. They going to establish a diagnostic normal or abnormal.
Time Frame
Day 0
Title
Range of compensation motion : "prone knee bend" test
Description
Lumbar extension measured for test number 6 "prone knee bend". Patients are filmed during the test. Videos are watched by three physiotherapists. They going to establish a diagnostic normal or abnormal
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Speed of execution for test 1
Description
It is measured with a camera. The camera can film one hundred pictures per second. Speed of execution is measured in seconds.
Time Frame
Day 0
Title
Speed of execution for test 2
Description
It is measured with a camera. The camera can film one hundred pictures per second. Speed of execution is measured in seconds.
Time Frame
Day 0
Title
Speed of execution for test 3
Description
It is measured with a camera. The camera can film one hundred pictures per second. Speed of execution is measured in seconds.
Time Frame
Day 0
Title
Speed of execution for test 4
Description
It is measured with a camera. The camera can film one hundred pictures per second. Speed of execution is measured in seconds.
Time Frame
Day 0
Title
Speed of execution for test 5
Description
It is measured with a camera. The camera can film one hundred pictures per second. Speed of execution is measured in seconds.
Time Frame
Day 0
Title
Speed of execution for test 6
Description
It is measured with a camera. The camera can film one hundred pictures per second. Speed of execution is measured in seconds.
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged more than 18 years Common low back pain with medical prescription for rehabilitation Signed consent Be affiliated to a social security scheme Be able to perform the lumbar motion control failure tests Exclusion Criteria: Body Mass Index greater than 30 (obesity) Person who does not understand French Pregnant woman Refusal to participate Volunteer under guardianship or curatorship
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vincent CREAC'H
Phone
+33(0)298017935
Email
vincent.creach@univ-brest.fr
Facility Information:
Facility Name
CHU de Brest
City
Brest
State/Province
Finistère
ZIP/Postal Code
29609
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent CREAC'H
Phone
+33(0)298017935
Email
vincent.creach@univ-brest.fr
First Name & Middle Initial & Last Name & Degree
Marine BOURHIS
First Name & Middle Initial & Last Name & Degree
Fanny GARGADENNEC
First Name & Middle Initial & Last Name & Degree
Thimothée HOUGRON

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected data that underlie results in a publication
IPD Sharing Time Frame
Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
IPD Sharing Access Criteria
Data access requests will be reviewed by the internal committee of Brest University Hospital. Requestors will be required to sign and complete a data access agreement.

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Does the Therapist's Assessment of Movement Control in Low Back Pain Patients Correspond to an Objective Kinematic Modification

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